The Equipment Coordinator is responsible for initial cGMP assessment of new equipment, coordination of equipment lifecycle documentation (change control, maintenance records, etc.) and equipment decommissioning. Additionally, this position will develop and maintain the NorthStar GMP automated Maintenance and Calibration Management System. They will also assist in executing tasks for commissioning and qualification testing for new facilities, utilities, and equipment as required.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:
1. Procedure Development – Assist in development and improvement of Good Engineering Practices (GEP) procedures related to Maintenance, Calibration, and Engineering Turnover Package (ETOP) for project closeout.
2. Manage the process of entering and maintaining equipment, instrument, and facility system maintenance information into the NorthStar CMMS (Computer Maintenance Management System).
3. Manage generation, assignment, issuance, and closeout of work orders for the Maintenance team to perform work on Facilities, Utilities, Equipment, and Instruments (for calibration).
4. Equipment Documentation Coordinator – Directly/indirectly ensure the completion and retention of forms submitted by NorthStar personnel for new equipment, instruments, or facility systems.
5. Project Coordination – Develop and maintain project numbering and tracking system, and ensure associated documentation correctly aligns with this system.
6. Interdepartmental Coordination – Coordinate Engineering documentation, storage and control needs with other groups responsible for document management software applications, such as Operations and Quality Assurance (QA)
7. Maintain engineering drawings in support of equipment projects and cGMP activities. This includes conversion of native-format drawings to final .pdf or other storage formats, and managing vendor-supplied drawings.
8. Create and control all types of technical documentation, as required, to support Engineering projects and tasks.
9. Assist in performance of Commissioning and Qualification test execution and documentation tasks.
10. Effectively communicate safety and quality issues raised by customers or staff in a timely manner.
11. Support NorthStar’s Quality System and Health & Safety Program by following policies and procedures.
Ability and willingness to travel up to 10% of the time.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Associates degree or equivalent from a two-year college or technical schools in a Science or Engineering related field and 2 years of experience of Equipment Coordination experience; or equivalent combination of education and experience. Experience with ERP programs such as SAP or Sage is required. Experience with team collaboration sites, ISO 9001 regulations, FDA cGMP and GLP compliance, and demonstrable experience with Master Control (or similar Process Module) preferred.
Proficient knowledge of Microsoft Office software programs, including Outlook, Word, and Excel.
• Excellent organization and writing skills
• Strong interpersonal and communication skills
• Strong attention to detail
If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line